Non-inferiority of Cataract Surgery in a Stand-Alone Unidirectional Airflow System Versus in a Conventional Operating Room: A Retrospective Study.

IF 2.9 3区医学 Q1 OPHTHALMOLOGY Journal of refractive surgery Pub Date : 2024-11-01 DOI:10.3928/1081597X-20241009-01

Sarah Partouche, Filippo Fabro, Artus Arnaud, Lucile Senicourt, Damien Gatinel, Christophe Panthier

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Abstract

Purpose: To demonstrate the non-inferiority of a stand-alone unidirectional airflow system, the SurgiCube (Surgi-Cube International BV), for cataract surgery compared to a conventional operating theater (OT).

Methods: This was a retrospective and comparative cross-sectional study conducted at the Rothschild Foundation, Paris, France. All patients who underwent cataract surgery using the SurgiCube between February 2020 and February 2023 were included and compared to a separate group of patients with cataract surgery performed in a conventional OT and under topical anesthesia during the same period. Patients with less than 1 month of follow-up after surgery were excluded. We collected relevant information from the patient's medical records. Main outcome measures, incidence of endophthalmitis, intraoperative and postoperative complication incidence, 1-month logarithm of minimum angle of resolution (logMAR) visual acuity and intraocular pressure, and operating times were analyzed.

Results: A total of 1,901 eyes in the SurgiCube group were compared to 5,474 eyes in the OT group. The occurrence of endophthalmitis was 0.05% (n = 1) in the SurgiCube group versus 0.07% (n = 4) in the OT group (P = 1.00; odds ratio = 0.72 [95% CI = 0.01 to 7.28]). The percentage of procedures with at least one perioperative complication was 2.6% in the SurgiCube group and 2.7% in the OT group (P = .87; odds ratio = 0.96 [95% CI = 0.68 to 1.34]). The percentage of procedures with a postoperative complication was 6.31% in the SurgiCube group and 6.6% in the OT group (P = .59; odds ratio = 0.94 [95% CI = 0.75 to 1.17]. Average visual acuity at 30 days was 0.04 logMAR in the SurgiCube group and 0.07 logMAR in the OT group (P = .62). The average operating times were 16.8 and 19.7 minutes for the SurgiCube and OT groups, respectively (P < .001). The average occupation room times were 26.2 and 32.3 minutes for the SurgiCube and OT groups, respectively (P < .001).

Conclusions: Cataract surgery in the SurgiCube seems to be non-inferior to cataract surgery in a conventional OT. [J Refract Surg. 2024;40(11):e884-e891.].

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独立单向气流系统与传统手术室中白内障手术的非劣效性：回顾性研究。

目的：证明在白内障手术中使用独立的单向气流系统 SurgiCube（Surgi-Cube International BV）与传统手术室（OT）相比没有劣势：这是一项在法国巴黎罗斯柴尔德基金会进行的回顾性横断面比较研究。研究纳入了 2020 年 2 月至 2023 年 2 月期间使用 SurgiCube 进行白内障手术的所有患者，并与同期在传统手术室和局部麻醉下进行白内障手术的另一组患者进行了比较。手术后随访不足 1 个月的患者被排除在外。我们从患者的病历中收集了相关信息。我们分析了主要结果指标、眼底病发生率、术中和术后并发症发生率、1个月最小分辨角（logMAR）视力和眼压对数以及手术时间：结果：SurgiCube 组共有 1,901 只眼睛，而 OT 组有 5,474 只眼睛。SurgiCube组眼底炎发生率为0.05%（n = 1），而OT组为0.07%（n = 4）（P = 1.00；几率比=0.72 [95% CI = 0.01至7.28]）。SurgiCube组至少出现一种围手术期并发症的手术比例为2.6%，OT组为2.7%（P = 0.87；几率比 = 0.96 [95% CI = 0.68 至 1.34]）。术后出现并发症的手术比例，SurgiCube 组为 6.31%，OT 组为 6.6%（P = .59；几率比 = 0.94 [95% CI = 0.75 至 1.17]）。手术立方组 30 天后的平均视力为 0.04 logMAR，OT 组为 0.07 logMAR（P = 0.62）。SurgiCube组和OT组的平均手术时间分别为16.8分钟和19.7分钟（P < .001）。手术立方组和手术室组的平均手术时间分别为 26.2 分钟和 32.3 分钟（P < .001）：结论：在 SurgiCube 中进行白内障手术似乎并不比在传统 OT 中进行白内障手术效果差。[J Refract Surg. 2024;40(11):e884-e891.]。

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来源期刊

$Journal of refractive surgery$

Journal of refractive surgery 医学-外科

CiteScore

5.10

自引率

12.50%

发文量

160

审稿时长

4-8 weeks

期刊介绍： The Journal of Refractive Surgery, the official journal of the International Society of Refractive Surgery, a partner of the American Academy of Ophthalmology, has been a monthly peer-reviewed forum for original research, review, and evaluation of refractive and lens-based surgical procedures for more than 30 years. Practical, clinically valuable articles provide readers with the most up-to-date information regarding advances in the field of refractive surgery. Begin to explore the Journal and all of its great benefits such as: • Columns including “Translational Science,” “Surgical Techniques,” and “Biomechanics” • Supplemental videos and materials available for many articles • Access to current articles, as well as several years of archived content • Articles posted online just 2 months after acceptance.